Taurolock for Preventing Bacterial Peritonitis During Renal Insufficiency

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01101087
First received: April 8, 2010
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

Dialysis catheters are sites of bacterial proliferation. The purpose of this study is to determine whether or not the use of Taurolock (a catheter lock solution) can prevent bacterial peritonitis in patients undergoing peritoneal dialysis.


Condition Intervention
Peritonitis
Catheter-related Infections
Renal Insufficiency
Device: Taurolock
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Efficacity of Taurolock in Preventing Primary Bacterial Peritonitis in Patients Undergoing Peritoneal Dialysis for Renal Insufficiency: a Randomized, Multicenter, Double Blind Study With Placebo

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Occurence of bacterial peritonitis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: July 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Taurolock Device: Taurolock
Placebo Comparator: Placebo Other: Placebo
Injectable sodium chloride conditioned in exactly the same manner as the experimental product.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Renal insufficiency, stage V (HAS 2007 classification)
  • Requires incident peritoneal dialysis
  • No signs of peritoneal infection on inclusion
  • signed consent
  • affiliated with a social security system

Exclusion Criteria:

  • Patient will have a renal transplant in the upcoming year following dialysis
  • Survival prognosis for one year is weak
  • allergy to citrate, (cyclo)-taurolidine, or heparin
  • patient is taking medication with a known contra-indication with citrate or (cyclo)-taurolidine
  • patient has a thrombopenia caused by heparin
  • impossible to inform the patient correctly
  • patient under guardianship
  • patient already included in another biomedical research protocol
  • no signed consent
  • no social security system
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101087

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nimes, Gard, France, 30029
CH d'Avignon - Centre Hospitalier Henri Duffaut
Avignon, France, 84902
CHU de Caen - Hôpital Clemenceau
Caen, France, 14033
CH de Chambéry
Chambery, France, 73011
CH de Colmar - Hôpitaux Civils de Colmar
Colmar, France, 68024
Association CALYDIAL Vienne
Irigny, France, 69540
Centre Hospitalier Départemental Vendée - Site de la Roche sur Yon
La Roche sur Yon, France, 85925
AIDER - Clinque Jacques Mirouze
Montpellier, France, 34295
APHP - Groupe Hospitalier Pitié-Salpetrière
Paris, France, 75651
CH Pontoise - Centre Hospitalier René Dubos
Pontoise, France, 95300
Association AUB Santé Quimper
Quimper, France, 29000
Centre Hospitalier Regional - Site Groupe Hospitalier Sud Réunion (GHSR)
Saint Pierre, France, 97448
CH de Valenciennes - Hôpital Jean Bernard et Hôtel Dieu
Valenciennes, France, 59322
ALTIR - Hôpital Brabois
Vandoeuvre les Nancy Cedex, France, 54504
French Polynesia
Association APURAD
Paéa, French Polynesia, 98711
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Bernard Branger, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01101087     History of Changes
Other Study ID Numbers: PHRC-N/2009/BB, 2009-A00599-48
Study First Received: April 8, 2010
Last Updated: March 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
France: The Commission nationale de l’informatique et des libertés

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Dialysis

Additional relevant MeSH terms:
Peritonitis
Renal Insufficiency
Catheter-Related Infections
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 31, 2014